Age-Related Macular Degeneration (ARMD) Clinical Trials

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A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration (ARTEMIS)

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug, Genetic
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to an active comparator. The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured at an average of Weeks 52 and 56. Safety, tolerability, and efficacy will be evaluated throughout the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits.

• Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1.

• At least 50 years old at Screening Visit 1.

• An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1.

• Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening

• Able to reliably use eye drops per protocol

Locations
United States
Arkansas
Adverum Clinical Site 198
RECRUITING
Springdale
Arizona
Adverum Clinical Site 223
RECRUITING
Gilbert
Adverum Clinical Site 126
RECRUITING
Phoenix
Adverum Clinical Site 178
RECRUITING
Phoenix
Adverum Clinical Site 229
RECRUITING
Scottsdale
Adverum Clinical Site 159
RECRUITING
Tucson
California
Adverum Clinical Site 109
RECRUITING
Bakersfield
Adverum Clinical Site 100
RECRUITING
Beverly Hills
Adverum Clinical Site 201
RECRUITING
Campbell
Adverum Clinical Site 172
RECRUITING
Encino
Adverum Clinical Site 169
RECRUITING
Fullerton
Adverum Clinical Site 224
RECRUITING
Huntington Beach
Adverum Clinical Site 215
RECRUITING
Redlands
Adverum Clinical Site 164
RECRUITING
Riverside
Adverum Clinical Site 140
RECRUITING
Sacramento
Adverum Clinical Site 212
RECRUITING
Sacramento
Adverum Clinical Site 175
RECRUITING
Santa Barbara
Adverum Clinical Site 202
RECRUITING
Torrance
Adverum Clinical Site 189
RECRUITING
Walnut Creek
Colorado
Adverum Clinical Site 200
RECRUITING
Denver
Adverum Clinical Site 116
RECRUITING
Lakewood
Connecticut
Adverum Clinical Site 165
RECRUITING
Waterford
Florida
Adverum Clinical Site 184
RECRUITING
Deerfield Beach
Adverum Clinical Site 176
RECRUITING
Fort Lauderdale
Adverum Clinical Site 221
RECRUITING
Fort Myers
Adverum Clinical Site 236
RECRUITING
Gainesville
Adverum Clinical Site 168
RECRUITING
Jacksonville
Adverum Clinical Site 214
RECRUITING
Lakeland
Adverum Clinical Site 213
RECRUITING
Orlando
Adverum Clinical Site 230
RECRUITING
Pensacola
Adverum Clinical Site 124
RECRUITING
Pompano Beach
Adverum Clinical Site 183
RECRUITING
South Miami
Adverum Clinical Site 120
RECRUITING
St. Petersburg
Adverum Clinical Site 193
RECRUITING
Tampa
Georgia
Adverum Clinical Site 182
RECRUITING
Augusta
Hawaii
Adverum Clinical Site 149
RECRUITING
‘aiea
Illinois
Adverum Clinical Site 179
RECRUITING
Oak Forest
Adverum Clinical Site 207
RECRUITING
Oak Park
Indiana
Adverum Clinical Site 195
RECRUITING
Carmel
Adverum Clinical Site 205
RECRUITING
Carmel
Maryland
Adverum Clinical Site 197
RECRUITING
Hagerstown
Adverum Clinical Site 204
RECRUITING
Hagerstown
Michigan
Adverum Clinical Site 167
RECRUITING
Detroit
Missouri
Adverum Clinical Site 190
RECRUITING
St Louis
Mississippi
Adverum Clinical Site 216
RECRUITING
Madison
Adverum Clinical Site 163
RECRUITING
Southaven
North Carolina
Adverum Clinical Site 196
RECRUITING
Asheville
Adverum Clinical Site 234
RECRUITING
Cary
Adverum Clinical Site 186
RECRUITING
Durham
Adverum Clinical Site 211
RECRUITING
Greensboro
Adverum Clinical Site 220
RECRUITING
Hickory
Adverum Clinical Site 209
RECRUITING
Wake Forest
Adverum Clinical Site 219
RECRUITING
Winston-salem
New Jersey
Adverum Clinical Site 171
RECRUITING
Teaneck
New York
Adverum Clinical Site 225
RECRUITING
Liverpool
Pennsylvania
Adverum Clinical Site 181
RECRUITING
Erie
Adverum Clinical Site 110
RECRUITING
Philadelphia
South Carolina
Adverum Clinical Site 208
RECRUITING
Charleston
Adverum Clinical Site 222
RECRUITING
Ladson
Adverum Clinical Site 122
RECRUITING
West Columbia
South Dakota
Adverum Clinical Site 144
RECRUITING
Rapid City
Texas
Adverum Clinical Site 123
RECRUITING
Abilene
Adverum Clinical Site 127
RECRUITING
Austin
Adverum Clinical Site 108
RECRUITING
Bellaire
Adverum Clinical Site 227
RECRUITING
Burleson
Adverum Clinical Site 194
RECRUITING
Dallas
Adverum Clinical Site 188
RECRUITING
Houston
Adverum Clinical Site 218
RECRUITING
Katy
Adverum Clinical Site 162
RECRUITING
Mcallen
Adverum Clinical Site 151
RECRUITING
San Antonio
Adverum Clinical Site 185
RECRUITING
San Antonio
Adverum Clinical Site 232
RECRUITING
San Marcos
Adverum Clinical Site 228
RECRUITING
Schertz
Adverum Clinical Site 107
RECRUITING
The Woodlands
Adverum Clinical Site 231
RECRUITING
The Woodlands
Virginia
Adverum Clinical Site 199
RECRUITING
Lynchburg
Washington
Adverum Clinical Site 131
RECRUITING
Spokane
Wisconsin
Adverum Clinical Site 187
RECRUITING
Wausau
West Virginia
Adverum Clinical Site 152
RECRUITING
Morgantown
Contact Information
Primary
Adverum Study Contact
ADVM02212ClinOp@adverum.com
650-656-9323
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2030-11-23
Participants
Target number of participants: 284
Treatments
Experimental: Ixo-vec
Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a single IVT injection of Ixo-vec 6 x 10\^10 vg/eye at Week 1, and sham injections every 8 weeks
Active_comparator: Aflibercept
Participants will receive 3 monthly loading doses of aflibercept 2 mg IVT, a sham injection at Week 1, and aflibercept 2 mg IVT every 8 weeks.
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Adverum Biotechnologies, Inc.

This content was sourced from clinicaltrials.gov

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